Dental appliance for improving airflow through nasal-pharyngeal airway

ABSTRACT

A dental device comprises an intraoral nasal dilator and a mandibular repositioner working synergistically as an anti-snoring device. The device has a lower segment of thermoplastic material which is formed to fit over the lower teeth and is connected to an upper section of molded material extending between the upper jaw and the upper lip by a wire connector. The wire connector has mechanisms allowing adjustment of the lower jaw positioning. A wire extension with acrylic pads at end is bonded in the midline of the flange and extends out so that the pads stretch the tissue of the lip and lateral nasal walls preventing collapse during respiration while the anterior repositioning of the lower jaw maintains opening of the posterior pharyngeal airway during sleep functioning as an anti-snoring device. Additional applications of the intraoral nasal dilator include incorporation into sports mouth guards using a variety of materials.

BACKGROUND FOR INVENTION—DISCUSSION OF THE PRIOR ART

[0001] Upper airway resistance to airflow is an affliction which affectsmillions of individuals and has very serious medical consequences withsignificant morbidity and mortality. The health effects are broughtabout by the disruption of normal sleep of those afflicted with snoringand sleep apnea (complete stoppage of breathing for a period of time).The effects of snoring and sleep apnea may also compromise the wellbeing of those sleeping in proximity to the afflicted person bydisrupting their ability to achieve healthy, restful sleep.

[0002] Sleep is impacted by both the increased effort needed to overcomeincreased resistance to airflow and by the fragmentation of sleeppatterns brought about by awakenings that occur in both hyponia (reducedair flow) and apneic events (periods of stoppage of air flow). Theseconditions limit one's ability to go into the deeper stages of sleepthat are necessary to refresh and restore and are damaging to many bodysystems.

[0003] The primary treatment for snoring and apnea is the use of adevice, referred to as a CPAP (Continuous Positive Air Pressure) device.This device delivers pressurized air from a pumping component through ahose to a mask which is secured over the nose of the individual. This issuccessful at correcting the problem but is not well tolerated by asignificant group of individuals due to the discomfort, lifestyleissues, and difficulty in the portability in traveling with the CPAP.Because of these factors a significant number of patients are forced toabandon the use of this therapy.

[0004] Surgical techniques have been available for many years; theseattempt to permanently correct snoring problems encountered byindividuals. However such surgical procedures are complicated andinvasive and sometimes permanently change the appearance of theindividual. In addition, numerous medical drawbacks, including cost,irreversibility, surgical risk, and long painful recovery periods, areinherent in surgical procedures.

[0005] Numerous devices are known which attempt to alleviate oreliminate snoring problem without invasive surgery. Some devices havefocused on improving airflow through the nose. These devices are usedboth in awake periods, during increased demand such as athletic usage,and during sleep to improve airflow as an anti-snoring device.

[0006] There are two mechanisms: one attaches to the external skin ofthe nose on the right and left sides of by means of adhesives which actby pulling the skin outward to strengthen and expand the nasal passages.(Ruch, U.S. Pat. No. 6,375,667, Apr. 23, 2002) This device is disposableand can irritate the skin. Other such devices are designed to fit insidethe nasal passageway and push the inner walls of the nose out, expandingthe air passage. (Corsaro, U.S. Pat. No. 5,727,543, Mar. 17, 1998). Thisdevice can irritate the sensitive inner lining of the mucosa of thenasal passageway and is awkward.

[0007] There are also numerous devices known which attempt to alleviateor eliminate snoring problems without invasive surgery by repositioningthe lower jaw (mandible) in an anterior (forward) direction. This pullsthe base of the tongue forward and thereby increases the air passage inthe posterior pharyngeal region (breathing passage behind the base ofthe tongue).

[0008] Devices which bring the mandible forward into a functionalrepositioning posture, and which hold the posterior airway open, fallinto two general categories. The first is non-adjustable: the devicefits in the mouth at a prescribed position. The disadvantage of this isthat there are changes over time that occur and therefore may requirechanging the position of the lower jaw in relationship to the upper jawover a period of time.

[0009] Devices which are adjustable have significant components insidethe mouth behind the teeth. They take up space inside the mouth,restricting the space for the tongue and preventing it from comingforward. Some devices also have projections which extend from the mouthout between the lips. These affect the user's ability to close theirlips, making the appliance less comfortable and inhibiting the abilityof the user to turn to different positions during sleep. Thus all knowndevices and techniques for improving airflow have one or more drawbacksor disadvantages.

BACKGROUND INVENTION—OBJECTS AND ADVANTAGES

[0010] Accordingly several objects and advantages of the presentinvention are:

[0011] (a) to provide an improved device for improving air flow throughthe nasal and pharyngeal air passage, preventing snoring and sleepapnea.

[0012] (b) To provide such a device that acts as a single unit and whichworks in a synergistic system

[0013] (c) to provide a nasal breathing aid which acts intraorally andcan be fixed in place by attachment to a device,

[0014] (d) to provide an anti-snoring device which maintains maximumintraoral tongue space,

[0015] (e) to provide such a device which is entirely contained withinthe oral cavity and does not extend out between the lips

[0016] Further objects and advantages are:

[0017] Still further, to provide a device for improved nasal breathingand providing additional protection form traumatic injury which isincorporated into athletic mouth guards.

[0018] Still further, to provide a mandibular repositioning device whichcan be used in orthodontic therapy.

[0019] Yet further objects and advantages will become apparent from areading of the ensuing descriptions and accompanying drawings.

SUMMARY

[0020] In accordance with this invention I provide a device forimproving airflow for breathing by stretching the skin of upper lipregion and the nose to maintain the free flow of air through the nasalair passage. The device comprises a base element that anteriorlyrepositions the lower jaw, thus repositioning the base of the tongueanteriorly. This reduces the resistance of airflow through thepharyngeal region by preventing the tongue from falling back duringsleep and obstructing the pharyngeal airway located in back of thetongue region.

DRAWINGS—FIGURES

[0021]FIG. 1 shows a front view of a device for nasal dilation andanti-snoring according to my invention.

[0022]FIG. 2 shows a lateral view of the device in FIG. 1.

[0023]FIG. 3 shows a posterior view of the device in FIG. 1.

[0024]FIG. 4 shows the superior view of the device in FIG. 1.

[0025]FIGS. 5A to 5D shows various aspects of an adjustable attachmentof a lower base section of the device of FIG. 1.

[0026]FIG. 6A shows a view looking down on upper dental splint.

[0027]FIG. 6B shows a lateral view of upper dental splint in place on adental cast.

[0028]FIG. 7 shows a midline cut view through the center of an upperanterior section of the device of FIG. 1.

[0029]FIG. 8 shows a lateral view of the device in FIG. 1 on dentalmodels.

[0030]FIG. 9A shows front view of device in FIG. 1 without nasaldilators for use as a mandibular repositioner.

[0031]FIG. 9B shows the mandibular repositioner of FIG. 9A in itsfunctional position shown on upper and lower dental models.

[0032] FIGS. 10A-C shows several alternative embodiments for athleticmouth guards.

[0033]FIG. 10D shows a cross-sectional cut view of fluid or air chamber.

[0034]FIG. 10E shows an athletic mouth guard with nasal labial dilatorbuttons

DRAWINGS—REFERENCE NUMERALS

[0035]10 thermoplastic base unit

[0036]12 left posterior section

[0037]18 left lateral wall

[0038]22 right occlusal wall

[0039]26 left lingual wall

[0040]28 right occlusal laminate

[0041]30 right attachment tube

[0042]32 left attachment tube

[0043]12 right posterior section

[0044]16 right lateral wa;;

[0045]20 left occlusal wall

[0046]24 right lingual wall

[0047]27 anterior lingual flange

[0048]29 left occlusal laminate

[0049]31 right outer tube

[0050]34 left outer tube

DETAILED DESCRIPTION—FIGS. 1-4

[0051] A preferred embodiment of a nasal dilator and anti-snoring deviceaccording to the invention is illustrated and FIG. 1 (anterior view),FIG. 2 (lateral view), FIG. 3 (posterior view), and FIG. 4 (top view).The device has a base unit 10, which fits over the lower teeth. It isconstructed of thermoplastic material, which is heat molded over adental model\ of the patient's teeth. In the preferred embodiment, thethermoplastic material used is 3 mm thick biocryl, available from GreatLakes Orthodontics of Tonawanda, N.Y. The biocryl is pressure moldedover the dental casts of the lower teeth using a Biostar thermoplasticmolding unit, available through Great Lakes Orthodontics.

[0052] The resultant molded form is cut in the inner side(lingual/tongue) of the dental arch approximately 3-5 mm below the uppermargin of the gum line from the back of the posterior-most tooth on theright completely around the dental arch to the posterior-most tooth onthe left. The molded material is then cut around the outer gingivalmargin of the molar and bicuspid teeth so that the material forms aright posterior section 12 with a right lateral wall 16, a rightocclusal wall 22, and right lingual wall 24, all of which encase theposterior teeth.

[0053] The device has a left posterior section 14, which is cut in asimilar fashion providing a left lateral wall 18, a left occlusal wall20, and a left lingual wall 26, which provide encasement of the leftposterior teeth.

[0054] The posterior sections provide coverage of the teeth and a meansof securing base unit 10 to the dental arch. The molded biocryl materialis next cut to remove the material on the facial or outer surface of theanterior teeth from the right canine tooth to the left canine tooth,leaving an anterior lingual flange 27 which extends from the insideupper edges of the anterior teeth to 3-5 mm below the gum-tooth margin.This completes base unit 10.

[0055] Base unit 10 can also be made of any other material which can beused to secure the lower dental arch, such as processed acrylics,hard-molded outer shell material with a soft inner lining, boil-and-bitematerials, preformed arch forms, or other commercially availablematerials.

[0056] Orthodontic headgear tubes, available from Posse Dental Supply ofOxnard, Calif., are used as right and left attachment tubes 30 and 32.Tubes 30 and 32 consists of outer tubes 31 and 34 and right and leftretention plates 36 and 37. Tubes 30 and 32 are placed over occlusalwalls 20 and 22 so that retention plates 36 and 37 lie across the top ofocclusal walls 20 and 22 at the area of the first molar tooth. Thiscreates right and left tubes 30 and 32 which are oriented so thatretention plates 36 and 37 lie over the occlusal walls and outer tubes31 and 34 are cantilevered out laterally. Other means of attachment maybe used, such as snap mechanisms and bonding of the joining mechanisms.

[0057] FIGS. 5A-D—Posterior Lower Base with Adjustment Components

[0058] FIGS. 5A-D show various views of posterior sections 12 and 13.Occlusal laminates for right and left sides 28 and 29 are made bycutting a piece of 1 mm biocryl to fit over right and left occlusalwalls 20 and 22, respectively. Each layer of occlusal laminates 28 and29 is bonded to respective occlusal walls 20 and 22 by a layer ofcold-cure acrylic. Plates 36 and 37 are bonded into their positions overthe first molar region lying between occlusal laminates 28 and 29 andocclusal walls 20 and 22, respectively. Multiple layers or greaterthicknesses of material can be used to increase the height of base unit10.

[0059] An orthodontic adjusting screw 113—in the preferred embodiment a3 mm Forestadent Standard Expansion Screw, available from Great LakesOrthodontics—is used. Orthodontic acrylic is applied to cover posteriorexpansion screw assembly 118 to form a posterior acrylic adjustment wall122. Screw 113 is positioned on lateral wall 16 below outer tube 31 sothat adjustment wall 122 butts up against anterior-vertical wire 70.Orthodontic acrylic is applied to the anterior expansion screw assembly114, bonding it to lateral wall 16. The adjustment segment of expansionscrew 116 and the posterior segment of expansion screw 118 remainunattached and free to move.

[0060] Adjustment segment of expansion screw 116 can be adjusted by akey (not shown). The key is a straight wire which can be inserted into ahole in adjustment nut 124 and used as a lever to rotate nut 124. As nut124 turns it expands the adjustment section 116, moving the freeposterior segment of the expansion screw 118 in a posterior direction.This pushes adjustment wire 50 moving it in a posterior directionthrough outer tube 31, carrying the repositioning flange 112 in aposterior direction. This adjustment is used to reposition the lower jawforward relative to the upper jaw to increase the repositioning effectof the device.

[0061] This process is repeated on the left side of the device.

[0062] A length of orthodontic wire is used as a right connecting andadjustment wire 50. In the preferred embodiment, Leone orthodontic wire,which is 1.1 mm in diameter, available from Posse Dental Supply, isused.

[0063] Wire 50 is bent 3 to 4 mm from its end at a 90-degree angle usingorthodontic pliers to form right anterior-vertical wire 70. Another bendis made 3 to 4 mm from the initial bend in a 90-degree angle aroundparallel axis from the first bend so as to form a right lower-horizontalwire 66. A third 90-degree bend is made 3 to 4 mm from the second andaround a parallel axis to the first two bends to form a rightdistal-vertical wire 62. This configuration forms right adjustmentsection 54.

[0064] Another length of orthodontic wire is cut and bent in the samemanner as wire 50 to form a left connecting-adjustment wire 52 andcorresponding left adjustment section 56 with its corresponding leftupper-horizontal wire 60, left distal-vertical wire 64, leftlower-horizontal wire 68 and left anterior-vertical wire 72. However thenumber of bends in right connecting-adjustment wire 50 and 52 can bereduced so that there is a 90-degree bend 8 mm from the end of the wire.A 180-degree foldback bend is made 4 mm in from the end of the wire tocreate right adjustment section 54 with a right anterior-vertical wire70 and a right distal-vertical wire 62.

[0065] Right wire 50 is inserted into the back of right outer tube 31 sothat adjustment section 54 is distal to outer tube 31 and right body ofconnecting wire 74 passes through the tube and extends anteriorly. Atthe junction of the first premolar and the canine tooth, a 90-degreebend is made parallel to the axis of the bands of adjustment section 54,forming right vertical rise of connecting wire 78. Another 90-degreebend is made so that the portion of wire anterior to right vertical riseof connecting wire 78 is directed towards the curve of the anteriordental arch, forming a right anterior face of connecting wire 82. Face82 is bent to form a curve around the anterior dental arch.

[0066] Left connecting-adjustment wire 52 is inserted into left outertube 34 and corresponding bends are made to form left body of connectingwire 76 of the left vertical rise of connecting wire 80 and the leftanterior face of connecting wire 84. Left and right anterior faces ofconnecting wires 82 in 84 meet at the midline.

[0067]FIG. 6—Midline Cut View Upper Segment

[0068]FIG. 6 shows a midline cut view of maxillary repositioning flange112.

[0069] A sheet of thermoplastic material is molded over the cast of theupper dental arch of the patient. In the preferred embodiment a 1 mmsheet of biocryl is used. However, other materials may be used, asdiscussed

[0070] A separating media sheet is molded over splint 104 and a sheet of3 mm biocryl is heat molded over the facial surface of the anterior ofthe splint 104 and the separating media. This molded material is removedand cut so that it extends from the junction of the first bicuspid toothand the canine tooth on one side to the junction of the first bicuspidtooth and canine tooth on the opposite side and form the edges of theanterior teeth up to the uppermost vestibular extension to form amaxillary flange 86.

[0071]7A-B—Upper Splint

[0072]FIG. 7A shows the maxillary dental splint 104 as seen looking downinto the inner surface of splint and FIG. 7B shows the dental splintplaced on a dental cast.

[0073] The sheet of biocryl, which has been molded over the upper dentalcast, is cut so that it extends over the dentition up to the gingivalmargins to form maxillary dental splint 104. Splint 104 is placed inposition over the occlusal side of base unit 10 and positioned so thatthe midline of the teeth lines up and the dental arch is oriented sothat the lower anterior teeth provide 1 to 3 mm forward of the upperanterior teeth. It can be positioned by using a dental cast mounted onan articulator using a bite registration taken on the patient in thedesired position to orient the dental casts on an articulatoralernatively it can be estimated and then adjusted on delivery.

[0074] Flange 86 is placed in position anterior to maxillary splint 104so that it fits between splint 104 and wires 82 and 84. Orthodonticacrylic is applied over wires 82 and 84, joining them to flange 86. Thebulk of orthodontic acrylic material used to attach wires 82 and 84 thatextend out from flange 86 to form an acrylic bumper 110. This unit formsmaxillary repositioning flange 112.

[0075] A length of orthodontic wire, in the preferred embodiment a 10 cmlength of 1.2 mm diameter Leone wire is used. A right button retentionloop 94 is bent at one end and a left button retention loop 96 is benton a parallel axis so that the final length of wire is equal to thecircumference of the dental arch from the lateral of the canine rootarea on the right side to the lateral to canine root area on left side.This is usually approximately 8 cm in length.

[0076] Two nasio-labial dilator buttons 88 are made by placing liquidorthodontic acrylic into previously made molds, which have a smoothspherical facial surface and a flat back surface. Buttons 88 are placedon a counter with the spherical surface facing down in a pre-made rubbermold. A nasio-label dilator body wire 92 is placed on top of the flatsurfaces of buttons 88 so that their loops 94 and 96 are centered overthe flat surface of buttons 88. Buttons 88 are bonded to loops 94 and 96by means of orthodontic acrylic, which is applied over the buttons,embedding the wire and bonding it to buttons 88. This forms a nasaldilator apparatus 87.

[0077] Dilator apparatus 87 is made to fit over maxillary flange 86 bycreating a band in body wire 92, which forms to the facial surface offlange 86. Nasal apparatus 87 is centered on the upper facial surface ofmaxillary flange 86. Orthodontic acrylic is applied over the centerportion of the wire laterally to the lateral incisor area to join nasalapparatus 87 to maxillary flange 86. Nasal apparatus 87 has right andleft free wire segments 98 and 100, which allow adjustment of buttons 88to position them in the vestibule at the correct height and distancefrom the maxilla. This creates the appropriate stretching of the upperlip and lateral nasal walls to maintain and stretch, therefore increasethe nasal canal to allow freer flow of air.

[0078] Operation—FIG. 8—Device in Place on Dental Models

[0079]FIG. 8 shows the device in position on a dental cast as it sitsover the teeth in the mouth. It positions and holds the lower jawforward. This forward posturing of the mandible prevents the jaw andtongue from moving posteriorly, thus preventing the patient's airwayfrom being compromised.

[0080] The user wears this device by placing it in their mouth as theyare going to sleep. Maxillary dental splint 104 sits over the upperteeth to support the teeth and distribute the forces of the mandiblethroughout the dental arch. Splint 104 is then snapped in over the teethand is held secure by the frictional force of the material around theteeth.

[0081] Specifically, the device is placed in the mouth with lower dentalarch secured in place by means of base unit 10 over the lower dentalarch and engaging it by snapping it over the teeth. Maxillaryrepositioning flange 112 is positioned anterior to the maxillary dentalarch with the maxillary splint. It is necessary for the patient toreposition their mandible forward as the lower jaw is closed in order toposition maxillary repositioning flange 112 in its proper functionalposition in front of the upper anterior teeth. The device then holds themandible in a more forward position and helps maintain the airway patentwhile allowing a degree of mobility of the jaw.

[0082] Nasal dilator apparatus 87 is positioned inside the upper lipsand stretches the lips to maintain the nasal air channel patent.

[0083] Gross adjustments of the mandibular repositioning can be made bybending right and left adjustment sections 54 and 56 in a manner whichpushes anterior vertical wires 70 and 72 anterior or posterior to theiroriginal position. More sensitive adjustments can be made by adjustingexpansion screw assembly 116 and expanding the screw, thereby pushingadjustment wire sections 54 and 56. Both of these methods of adjustmentact by moving adjustment wires 50 and 52 and maxillary repositioningflange 112 in a posterior direction, therefore moving the mandible in amore anterior direction.

[0084] Nasal dilator apparatus 87 can be adjusted by bending free wiresegments 98 and 100 to alter the position of buttons 88 so that theycause stretching of the nasal labial tissue. This stretch increases thetension of the lateral walls of the nose, increasing the strength ofthese walls against the collapsing forces of inspiration. This allowsair to move through the nasal passage with greater ease, resulting ingreater airflow and a lessening of the negative pressure created ininspiration. Decreasing the negative pressure in the nasal regiondecreases it in the entire respiratory channel and works with themandibular repositioning to improve the function of the device.

[0085] FIGS. 9A-9B—Additional Embodiments

[0086] Additional embodiments are shown in FIGS. 9A and 9B; FIG. 9Ashows the front view of the device for mandibular reposition which hasuses for orthodontic care. FIG. 9B shows device in place repositioningthe mandible forward. This embodiment functions as a mandibularrepositioning device which can be used for snoring and sleep apneatherapy or in orthodontics as the device to reposition the mandible andstimulate the growth of the mandible in orthodontic treatment. Itdiffers form the preferred embodiment utilizes the device without nasaldilator apparatus 87.

[0087] FIGS. 10A-10E—Alternative Embodiments

[0088]FIGS. 10A and 10B. show frontal and lateral views of an athleticmouth guard which is constructed of molded commercially availablematerials shaped to extend up into the space between the upper jaw andthe upper lip and stretch the nasal-labial soft tissue to function as anasal dilator.

[0089]FIG. 10C. shows an additional alternative embodiment of anathletic mouth guard of similar form to that of FIGS. 10A and B. Thiscontains a chamber in the flange which extends into the space under theupper lip. This space can be filled with substance which allows controlof the pressure in the chamber. This chamber can be pressurized bysubstances such as liquid or air and allows adjustment of the volume ofthe flange thereby adjusting the control of effect of tissue stretch andalso providing a cushioning and protecting effect of the mouth guard.

[0090]FIG. 10D shows a cross-section through the device in FIG. 10C. Thedevice fits over the teeth as a mouth guard and extends between theupper jaw and the upper lip. This cross-section shows the chamber with avalve in which an injection syringe (not shown) can be used topressurize the chamber.

[0091]FIG. 10E shows an additional embodiment. Nasal dilator apparatus87 is attached to a mouth guard which can be used in non-contactactivities.

[0092] Conclusion, Ramifications, and Scope

[0093] Thus the reader will see that this device creates improvedairflow through the nasal and pharyngeal regions. It is used at nightduring sleep in the treatment of snoring and sleep apnea, which aremedical conditions which carry significant medical morbidity andmortality. It can also be used to enhance breathing in times of neededmaximal nasal pharyngeal respiration during waking activities such asduring athletic activities.

[0094] Resistance to air flow through the nasal and posterior pharyngealairway lead to snoring and sleep apnea. This health condition has asignificant impact on millions of people. This device functions toprevent the closure of the breathing passageways in both the nose andthroat regions.

[0095] These goals are accomplished because the device maintains maximumintraoral volume and eliminates the need for components which extendthrough the lips, outside of the mouth. It provides adjustability andsignificant degree of motion, which reduces strain on the dentition.

[0096] The advantages of this appliance are the synergistic effect ofmaintaining the airway in two different areas of resistance at the sametime with one device. It accomplishes this with a device that is easy touse, has a minimal of material interfering with the tongue, has nocomponents which extend out through lips, and which minimizes discomfortand forces on the teeth.

[0097] While my above description contains many specificities, theyshould not be construed as limitations to the scope of the invention,but rather as an exemplification of one preferred embodiment. Many othervariations are possible. For example the nasal dilator apparatus can beconstructed in a way so that it can be incorporated into sports mouthguards which can function both as a means maintaining maximum airflowthrough the nose while providing a cushion to protect the face duringcontact sport. This embodiment can use chambers, which contain air orliquid, which create a volume of material under the upper lip in thevestibule, which stretch as the nasal labial tissue and provides acushion for impacts on the facial region.

[0098] The apparatus can also consist of molded acrylic material,plastics, or molded material forming a chamber, which contains air underpressure or water that creates hydraulic pressure. The pressure of thischamber can be constructed to allow adjustability of the size andpressure of the nasal dilator apparatus by means of a valve, whichallows addition or subtraction of air or liquid.

[0099] Other uses of this device are for treatment of mouth breathers,who have developed a short upper lip. The device can be used to stretchthe upper lip. The device can also be used in orthodontics as a lowerjaw repositioner to correct malocclusions.

[0100] Accordingly, the scope of the invention should be determined, notby the embodiments illustrated, but by the appended claims and theirlegal equivalents.

1. A device for reducing resistance of air flow in the breathingpassages during awake activities, and providing an anti-snoring devicefor the treatment of obstructive sleep apnea during sleep, andmandibular repositioning comprising: (a) a lower section mountable uponthe lower jaw; (b) an upper section which extends between the upperteeth and lip, (c) a connection apparatus which joins said lower sectionwith said upper section, (d) a structure fitting in the vestibule of themaxilla underneath the lips for stretching the nasal-labial tissue tostretch and strengthen the nasal walls, providing an intraoral nasaldilator to increase the volume in the nasal channel, thereby decreasingthe resistance to airflow, (e) a means for securing said structure tosaid upper section for stretching nasal labial tissue, and (f) a meansfor adjusting the relative position of said upper section to said lowersection,
 2. The device of claim 1 wherein said lower section is shapedto fit securely over the lower teeth.
 3. The device of claim 2 whereinsaid lower section is composed of molded thermoplastic material.
 4. Thedevice of claim 2, further including means for attaching said lowersection to said upper section.
 5. The device of claim 4 wherein saidlower section is comprised of a metal tube with a flat attachment platewhich is positioned above the upper surface of said lower section in thearea of the first molar tooth on each side, with said metal tube facingout laterally and being secured in place by a intervening layer ofcold-cure acrylic embedding said flat attachment plate into positionover the first molar area of said lower section and forming a flat topsurface.
 6. The device of claim 5, further including an adjustmentcomponent comprising an orthodontic expansion screw, said screw havingan anterior structure bonded with cured acrylic to the lateral wall ofsaid lower section with the posterior structure of said expansion screwfree to move during adjustment.
 7. The device of claim 6, furtherincluding a plurality of metal wires placed through said respectivemetal tubes on the right and left side of said lower section andconnecting said lower section to said upper section.
 8. The device ofclaim 7 wherein said metal wire section posterior to said metal tube isbent in a plurality of right angles, around an axis parallel to formequal-length segments of wire with the most anterior segment positionedabutting said posterior wall of said adjustment component.
 9. The deviceof claim 7 wherein the anterior lengths of said metal wire bent at a90-degree angle at the anterior of the first bicuspid tooth and again ata 90-degree angle in the direction of the tangent of the curve of theupper opposing dental arch and then follow the curve of the upper archtowards the dental midline.
 10. The device of claim of 6 wherein saidupper and lower sections are connected to each other by said metal wireattached to said lower section by said wire extending through said metaltube and bonded to said upper section.
 11. The device of claim 10,further including means for adjusting the relationship of said uppersection to said lower section by pulling said wire through said metaltube in a posterior direction to carry said upper section in a moreposterior direction to said lower section.
 12. The device of claim 11wherein said means for adjusting includes a segment of wire bent in aplurality of bends which can be altered by bending the wires as amechanism for altering of the relationship of said upper section to saidlower section.
 13. The device of claim 11, further including said meansfor adapting said adjustment component comprising said orthodonticexpansion screw which can be adjusted moving said posterior structurepushing said metal wire through said metal tube altering therelationship of said upper section to said lower section.
 14. The deviceof claim 1 wherein said maxillary structure is arranged to fit in thevestibule of the upper jaw underneath the upper lip to stretch thenasal-labial tissue to strengthen and open of the nasal walls as anintraoral nasal dilator which maintains greater volume in the nasalchannel, thereby decreasing the resistance to airflow
 15. The device ofclaim 14 wherein said maxillary structure comprises a plurality oflateral extensions shaped in a plural of different forms, where saidextensions contact the upper lip.
 16. The device of claim 15, furtherincluding a connector for joining said lateral extensions.
 17. Thedevice of claim 16, further including means for joining said maxillarystructure to said upper section.
 18. A device for improving airflowthrough the nasal and pharyngeal regions, comprising: (a) means forrepositioning the mandible and maintaining the oral pharyngeal airwaycomprising: i: a device comprising:
 1. a lower section molded to fitsecurely over the lower dentition, said lower section constructed ofthermoplastic material molded over a patient's lower dental casts andcut to fit over the molar and bicuspid teeth on the outside of themargin of the gum and teeth and behind the canine and incisor teeth fromthe incisal edges down the inside to form a connecting segment, theinside margins of saidlower section extending below the gingival marginsaround the entire inner arch,
 2. a metal tube with a flat rectangularextension which secures said tube to said lower segment, allowing saidtube to extend out laterally,
 3. a laminate of a flat occlusal sheet ofthermoplastic material cut to fit over the molar and bicuspid teeth oneach side, said sheet being bonded to the occlusal surface of theposterior tooth region of said lower section to embed said tubeextension, providing a flat top surface,
 4. an orthodontic expansionscrew attached to the lateral wall of said lower segment so that theadjustment and posterior segments remain unattached and will move in aposterior direction as the expansion screw is opened ii. a wire thatfits through metal tube on the lateral sides of lower segment with threefunctional regions:
 1. a posterior adjusting region which extendsposterior to metal tube and is bent in a box-like form in a single planehaving the free end of said wire at the anterior superior corner so theend of said wire can be moved by bending said wire for adjustability, 2.a middle straight segment of said wire extending anteriorly throughmetal tube functioning to secure wire while allowing wire to slideduring adjustment,
 3. an anterior region which bends up at a 90-degreeangle at the region of the first bicuspid and then again anteriorly toextend around the arc of upper dental arch, providing a connector tosaid lower section and upper section, iii. an upper section of moldedthermoplastic material which extends in front of the upper canine andincisor teeth from the incisal edge of the teeth up into the vestibuleof the upper jaw and bonded to the anterior curve of said wire creatinga functional unit with lower section, (b) an apparatus which extends upinto the maxilla vestibule and which is secured to base apparatus whichstretches the soft tissue of the nasal-labial region strengthening andpreventing collapse of the tissue under the vacuum created duringinspiration, maintaining the opening of a nasal airway, i. saidapparatus comprising a plurality of acrylic semi-spherical buttons withthe flat side bonded to a wire connector so that the curved sphericalsurface faces outward, ii. said wire connector with said buttons beingattached to said upper section by cold-cure acrylic in the middle,leaving the lateral ends of said wire free, providing a region that canbe bent to adjust the position of buttons to stretch the nasal-labialtissue, and (c) a splint for the upper teeth formed by a plurality ofmaterials which are molded over upper dental casts and cut to form alayer of molded plastic extending over all of the teeth in the upperdental arch.
 19. A method for holding the lower jaw in a forward postureand stretching the nasal labial tissue for the purpose of improvingairflow and reducing resistance to breathing, snoring, and sleep apnea,comprising: (a) stretcheing the soft tissue of the lip and nose with astretching device to dilate the nasal passage, creating a strengtheningof the nasal canals to the forces of inspiration, (b) positioning themandible forward using a positioning device which fits over the lowerteeth and has a retention component and (c) protecting the teeth andstretching the soft tissue of the lip and nose with a plurality ofathletic mouth guards that cover the dentition and extend into the areabetween the upper jaw and lip to maximize nasal airflow during times ofexertion during athletic endeavors,
 20. The method of claim 19, furtherincluding providing a device that acts to improve airflow in theoral-nasal region by a lower section fitted securely over the lowerdentition and an upper section extending in front of the upper anteriorteeth into the vestibule between the lip and the upper jaw to hold themandible in a protruded posture, preventing restrictions in theposterior airway and structure extending under the upper lip to stretchthe nasal labial tissue, dilating the nasal air passage,
 21. The methodof claim 20, further including providing a plurality of adjustmentelements which allow alteration of the relationship of said lowersection to said upper section as a means of adjusting the amount offorward posturing of the lower jaw,
 22. The method of claim 21, furtherincluding providing a upper splint which fits over the upper teeth anddistributes the forces created by the muscle pull of the lower jawwhereby when said device fits inside the user's mouth, it maintainsmaximum tongue space while providing a single unit which has the dualfunction of function maintaining airflow through both of the nose andthroat regions.